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This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied.
The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | AZD7687 oral suspension |
|
| Placebo | Experimental | placebo oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7687 | Drug | Single oral dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters. | ||
| Exploratory pharmacogenetic blood sampling. | ||
| Pharmacodynamic biomarker sampling; blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| C578442 | AZD7687 |
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| Drug |
Single oral dose |
|